Hydroxyurea in the Emergency Room to Lessen Pain in Sickle Cell Crisis

Anemia, Sickle Cell Clinical Trial

— HELPS  

Official title:

Protocol for the Administration of Hydroxyurea During Painful Vaso-occlusive Crisis in Sickle Cell Anemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03062501
• Other study ID #: Hemorio 397/16
• Status: Recruiting
• Phase: Phase 2
• First received: January 30, 2017
• Last updated: February 20, 2017
• Start date: November 2016
• Est. completion date: July 2017

Study information

• Verified date: February 2017
• Source: Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti
• Contact: Clarisse Lobo, MD
• Phone: + 55 (21) 98133-3606
• Email: lobo.clarisse[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the safety, tolerability and potential for the use of up to three daily doses of 30-40 mg/kg HU (daily) upon hospitalization for painful vaso-occlusive crises .

Description:

Sickle cell anemia (SCA) is a hereditary hemoglobinopathy; complications of the disease include, spleen enlargement, acute chest syndrome, pulmonary hypertension, stroke and cumulative damage to multiple organs, and painful vaso-occlusive crises (VOC). In Brazil, about 3,500 children are born each year with DF, and the number of individuals with sickle cell disease (DF) in the country is estimated between 25,000 and 30,000 (ANVISA 2012; BRAZIL, 2012).

Hydroxyurea (HU, or hydroxycarbamide) is the only drug approved to date by the American FDA for use in adults with sickle cell disease. The drug modifies the disease process, improving hematological parameters and the hospitalization time of patients, as well as the frequency of vaso-occlusive crises.In addition to its proven effects during chronic use, experimental data indicate that HU has immediate anti-inflammatory effects.

In addition to its proven effects during chronic use, experimental data indicate that HU has immediate anti-inflammatory effects. This study will investigate the safety, tolerability and potential for the use of up to three daily doses of 30-40 mg/kg HU (daily) upon hospitalization for VOC.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of homozygous sickle cell anemia (HbSS).

• Hospitalization due to onset of uncomplicated vaso-occlusive crisis (with pain scale=6 within the last 24 h), confirmed by clinical evaluation.

• Documented and written informed consent

Exclusion Criteria:

• Confirmed or suspected pregnancy.

• Initiation of painful crisis> 72h.

• Blood transfusion during the last 8 weeks.

• Admission to Emergency Room due to pain in the last 4 weeks.

• Neutrophil count <2.5 x 109/L or platelet count <95.0 x 109 / L or Hb <4.5 g / dL

• Weight <38 Kg or> 95 Kg.

• Interval longer than 8h since arrival at center.

• Non-consent to participate in the study.

Related Conditions & MeSH terms

• Anemia
• Anemia, Sickle Cell
• Anemia; Sickle-Cell, With Crisis

Intervention

Drug:
• Hydroxyurea
Patients hospitalized for uncomplicated pain crisis with a pain scale of = 6 during the last 24 hours will receive a dose of 30-40 mg / kg hydroxyurea. This same dose of hydroxyurea will be repeated at 24 h and 48 h after the first dose of hydroxyurea, with dose suspension if the patient is discharged within 48 hours. Patients will also receive the center's usual practice and analgesia protocol.

Locations

Country	Name	City	State
Brazil	Hemorio	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events	as assessed by CTCAE version 4.03	up to 15 days post last dose
Primary	Number of participants with altered laboratory values related to treatment		up to 15 days post last dose
Secondary	Time until hospital discharge		Average, up to 7 days post admission
Secondary	Total opioid use (mg of IV morphine)		From study inclusion until hospital discharge (average, up to 7 days post admission)
Secondary	Pain score	Numeric pain score rating (0 to 10; 0 = no pain, 10 = worst pain)	From admission until hospital discharge (average, up to 7 days post admission)